By Phil Taylor
30-Apr-2010
Artesunate product - The Cambodian government has completed a major anti-counterfeiting operation which has led to the closure of around 65 per cent of the illegal pharmacies operating in the country, according to the US Pharmacopeia.
Five manufacturers have also been banned from supplying products in Cambodia, said the USP, which supported the operation via its work on the Promoting the Quality of Medicines (PQM) project, funded by the US Agency for International Development (USAID).
The crackdown, conducted over five months, targeted the illegal pharmacies because of evidence they were "among the primary sources of substandard and counterfeit medicines in the country," said the USP in a statement.
Between November 2009 and March 2010 the number of illegal pharmacies in operation was slashed from 1,081 to 379, according to data from the Cambodian Ministry of Health.
The operation is a major success for Cambodia's Inter-Ministerial Committee to Fight against Counterfeit & Substandard Medicines (IMC), which was set up in 2005 after a study showed that 16.2 per cent of malaria drugs sampled from retail pharmacy outlets in four Cambodian provinces were of poor quality.
Since then, there has been an alarming decline in therapeutic efficacy of recommended first-line antimalarials, e.g. artemisinin-based combination therapies (ACTs) on the Cambodia-Thailand border which has been attributed to the prevalence of counterfeit and substandard antimalarial drugs, as well as general problems with healthcare provision.
The counterfeiters have also become increasingly sophisticated, carrying various types of fake holograms, and researchers headed by Paul Newton at the Centre for Tropical Medicine in Oxford, UK, have been engaged in chemical, mineralogical, biological, and packaging studies which indicate at least some the counterfeits were manufactured in the southeast region of China.
And the problem is also not confined to malaria drugs. More recently, a similar survey of antihelminthic medicines used to treat parasitic worm infections, published in the journal Tropical Medicine & International Health (May 2010), revealed that around 4 per cent of samples collected from private drug outlets were fake.
The emphasis of the PQM programme in the country is currently on antimalarials and antibiotics, according to the USP.
Meanwhile, through the IMC, Cambodia has also been running public awareness campaigns on television to warn of the dangers of counterfeits, focusing particularly on antimalarials, as well as alerts to warn healthcare professionals to be on the lookout.
Other partners in the latest operation included the World Health Organization (WHO) and the Global Fund to Fight AIDS, Tuberculosis, and Malaria.
-------------------------------
Cambodia Takes Action In Fight Against Substandard And Counterfeit Medicines
Medical News Today
In a major crackdown, Cambodia has forced nearly 65 percent of illegal pharmacies operating in the country to close within the past five months. Led by an Inter-Ministerial Committee to Fight against Counterfeit & Substandard Medicines (IMC), the shops were targeted because of evidence that they were among the primary sources of substandard and counterfeit medicines in the country. This evidence was generated from medicines quality monitoring activities conducted in Cambodia by the Promoting the Quality of Medicines (PQM) Program, a U.S. Agency for International Development (USAID)-funded program implemented by the U.S. Pharmacopeial Convention (USP), with additional support from The Global Fund to Fight AIDS, Tuberculosis, and Malaria and the World Health Organization.
The string of recent activity by the Cambodian government has resulted in a reduction of illegal outlets from 1,081 in November 2009 to 379 in March 2010, or 64.9 percent, according to an April report by the Cambodian Ministry of Health. As part of this effort, the government also banned sales of products from five manufacturers in the country. These actions are an outgrowth of the IMC, which consists of Cambodia's Ministries of Health; Interior; Justice; Information; Commerce; Education, Youth and Sport; Economy and Finance; Agriculture, Forestry and Fisheries; and Municipality of Phnom Penh.
The IMC was formed in 2005 under the direction of the Cambodian government after 2004 figures showed that 16.2 percent of antimalarials sampled from retail pharmacy outlets in the private sector of four provinces were of poor quality. A major barrier identified in combating the presence of these medicines was lack of coordination among the various ministries. With financial and technical support from the USAID-USP program, the group developed an action plan to significantly reduce the number of substandard and counterfeit medicines. A January 2010 official order to close down illegal health services, including pharmacy outlets across the country, was the impetus for much of this recent progress.
"The resolution in such a short period of time is a major accomplishment on the part of the Cambodian government - and a significant step forward in assuring the quality of life-saving medicines for patients in the country," said Richard Greene, director of the USAID Office of Health, Infectious Diseases and Nutrition, Bureau for Global Health.
According to Patrick Lukulay, Ph.D., director of the PQM Program, "In the face of many challenges and spotty public awareness of the dangers of taking poor-quality medicines, this represents momentous progress. I am gratified that USAID-USP's PQM Program was able to contribute in this effort - part of our broader work to combat the proliferation of substandard and counterfeit medicines. We look forward to a continuing partnership with Cambodia to address this problem, which will ultimately result in advancing the public health."
The PQM Program (and a predecessor USAID-USP program) has been active in Cambodia since 2003, providing technical assistance to support the establishment and continued strengthening of a postmarketing surveillance program tracking the quality of antimalarial, anti-tuberculosis, antibiotic and antiretroviral medicines available to citizens. The current emphasis of the PQM Program in the country is on antimalarials and antibiotics. Much of this work is done through 12 "sentinel sites" established in the country by the PQM Program with additional support from The Global Fund, which are equipped with portable laboratories called Minilabs® that are used to detect substandard and fake medicines. Other PQM activities include organizing and conducting training workshops on good manufacturing practices and other topics, and providing critical laboratory equipment, supplies, and training on proper use and maintenance of equipment to the National Health Product Quality Control Center.
The PQM Program serves as a primary mechanism to help assure the quality, safety and efficacy of medicines that are essential to USAID's priority health programs. USAID is a U.S. government agency that provides economic, development and humanitarian assistance around the world in support of the foreign policy goals of the United States. USP, which implements the program, is a nonprofit scientific organization that develops globally recognized standards for the quality of medicines. The PQM Program is currently active in 30 countries throughout Asia, Africa and Latin America.
Source:
Francine Pierson
US Pharmacopeia
Five manufacturers have also been banned from supplying products in Cambodia, said the USP, which supported the operation via its work on the Promoting the Quality of Medicines (PQM) project, funded by the US Agency for International Development (USAID).
The crackdown, conducted over five months, targeted the illegal pharmacies because of evidence they were "among the primary sources of substandard and counterfeit medicines in the country," said the USP in a statement.
Between November 2009 and March 2010 the number of illegal pharmacies in operation was slashed from 1,081 to 379, according to data from the Cambodian Ministry of Health.
The operation is a major success for Cambodia's Inter-Ministerial Committee to Fight against Counterfeit & Substandard Medicines (IMC), which was set up in 2005 after a study showed that 16.2 per cent of malaria drugs sampled from retail pharmacy outlets in four Cambodian provinces were of poor quality.
Since then, there has been an alarming decline in therapeutic efficacy of recommended first-line antimalarials, e.g. artemisinin-based combination therapies (ACTs) on the Cambodia-Thailand border which has been attributed to the prevalence of counterfeit and substandard antimalarial drugs, as well as general problems with healthcare provision.
The counterfeiters have also become increasingly sophisticated, carrying various types of fake holograms, and researchers headed by Paul Newton at the Centre for Tropical Medicine in Oxford, UK, have been engaged in chemical, mineralogical, biological, and packaging studies which indicate at least some the counterfeits were manufactured in the southeast region of China.
And the problem is also not confined to malaria drugs. More recently, a similar survey of antihelminthic medicines used to treat parasitic worm infections, published in the journal Tropical Medicine & International Health (May 2010), revealed that around 4 per cent of samples collected from private drug outlets were fake.
The emphasis of the PQM programme in the country is currently on antimalarials and antibiotics, according to the USP.
Meanwhile, through the IMC, Cambodia has also been running public awareness campaigns on television to warn of the dangers of counterfeits, focusing particularly on antimalarials, as well as alerts to warn healthcare professionals to be on the lookout.
Other partners in the latest operation included the World Health Organization (WHO) and the Global Fund to Fight AIDS, Tuberculosis, and Malaria.
-------------------------------
Cambodia Takes Action In Fight Against Substandard And Counterfeit Medicines
Medical News Today
In a major crackdown, Cambodia has forced nearly 65 percent of illegal pharmacies operating in the country to close within the past five months. Led by an Inter-Ministerial Committee to Fight against Counterfeit & Substandard Medicines (IMC), the shops were targeted because of evidence that they were among the primary sources of substandard and counterfeit medicines in the country. This evidence was generated from medicines quality monitoring activities conducted in Cambodia by the Promoting the Quality of Medicines (PQM) Program, a U.S. Agency for International Development (USAID)-funded program implemented by the U.S. Pharmacopeial Convention (USP), with additional support from The Global Fund to Fight AIDS, Tuberculosis, and Malaria and the World Health Organization.
The string of recent activity by the Cambodian government has resulted in a reduction of illegal outlets from 1,081 in November 2009 to 379 in March 2010, or 64.9 percent, according to an April report by the Cambodian Ministry of Health. As part of this effort, the government also banned sales of products from five manufacturers in the country. These actions are an outgrowth of the IMC, which consists of Cambodia's Ministries of Health; Interior; Justice; Information; Commerce; Education, Youth and Sport; Economy and Finance; Agriculture, Forestry and Fisheries; and Municipality of Phnom Penh.
The IMC was formed in 2005 under the direction of the Cambodian government after 2004 figures showed that 16.2 percent of antimalarials sampled from retail pharmacy outlets in the private sector of four provinces were of poor quality. A major barrier identified in combating the presence of these medicines was lack of coordination among the various ministries. With financial and technical support from the USAID-USP program, the group developed an action plan to significantly reduce the number of substandard and counterfeit medicines. A January 2010 official order to close down illegal health services, including pharmacy outlets across the country, was the impetus for much of this recent progress.
"The resolution in such a short period of time is a major accomplishment on the part of the Cambodian government - and a significant step forward in assuring the quality of life-saving medicines for patients in the country," said Richard Greene, director of the USAID Office of Health, Infectious Diseases and Nutrition, Bureau for Global Health.
According to Patrick Lukulay, Ph.D., director of the PQM Program, "In the face of many challenges and spotty public awareness of the dangers of taking poor-quality medicines, this represents momentous progress. I am gratified that USAID-USP's PQM Program was able to contribute in this effort - part of our broader work to combat the proliferation of substandard and counterfeit medicines. We look forward to a continuing partnership with Cambodia to address this problem, which will ultimately result in advancing the public health."
The PQM Program (and a predecessor USAID-USP program) has been active in Cambodia since 2003, providing technical assistance to support the establishment and continued strengthening of a postmarketing surveillance program tracking the quality of antimalarial, anti-tuberculosis, antibiotic and antiretroviral medicines available to citizens. The current emphasis of the PQM Program in the country is on antimalarials and antibiotics. Much of this work is done through 12 "sentinel sites" established in the country by the PQM Program with additional support from The Global Fund, which are equipped with portable laboratories called Minilabs® that are used to detect substandard and fake medicines. Other PQM activities include organizing and conducting training workshops on good manufacturing practices and other topics, and providing critical laboratory equipment, supplies, and training on proper use and maintenance of equipment to the National Health Product Quality Control Center.
The PQM Program serves as a primary mechanism to help assure the quality, safety and efficacy of medicines that are essential to USAID's priority health programs. USAID is a U.S. government agency that provides economic, development and humanitarian assistance around the world in support of the foreign policy goals of the United States. USP, which implements the program, is a nonprofit scientific organization that develops globally recognized standards for the quality of medicines. The PQM Program is currently active in 30 countries throughout Asia, Africa and Latin America.
Source:
Francine Pierson
US Pharmacopeia
No comments:
Post a Comment